TY - JOUR T1 - Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study JF - Gut JO - Gut SP - 1061 LP - 1068 DO - 10.1136/gutjnl-2013-304722 VL - 63 IS - 7 AU - Kentaro Sugano AU - Myung-Gyu Choi AU - Jaw-Town Lin AU - Shinya Goto AU - Yasushi Okada AU - Yoshikazu Kinoshita AU - Hiroto Miwa AU - Chern-En Chiang AU - Tsutomu Chiba AU - Masatsugu Hori AU - Yasushi Fukushima AU - Hyun-Soo Kim AU - Chi-Yang Chang AU - Masataka Date AU - on behalf of the LAVENDER Study Group Y1 - 2014/07/01 UR - http://gut.bmj.com/content/63/7/1061.abstract N2 - Objectives To evaluate if esomeprazole prevents recurrent peptic ulcer in adult patients with a history of peptic ulcer receiving low-dose acetylsalicylic acid (ASA, aspirin) for cardiovascular protection in East Asia. Methods In this prospective, randomised, double-blind, placebo-controlled trial conducted in Japan, Korea and Taiwan, eligible patients receiving low-dose ASA for cardiovascular protection (81–324 mg/day) were randomised to esomeprazole 20 mg/day or placebo for ≤72 weeks. All patients received concomitant mucosal protection (gefarnate 100 mg/day). The primary endpoint was time to ulcer recurrence (Kaplan–Meier analysis). Efficacy findings are presented up to week 48, as per a planned interim analysis within the study protocol. Results A total of 364 patients (79.9% men; mean age, 67.1 years) comprised the full analysis set (esomeprazole, n=182; placebo, n=182). There was a statistically significant difference in the time to ulcer recurrence between esomeprazole and placebo (HR 0.09; 96.65% CI 0.02 to 0.41; p<0.001). The estimated ulcer-free rate at week 12 was 99.3% (esomeprazole) and 89.0% (placebo). The high estimated ulcer-free rate for esomeprazole was maintained through to week 48 (98.3% vs 81.2% of placebo-treated patients). No factors, other than female gender, reduced time to ulcer recurrence in addition to the effect of esomeprazole (p<0.001). Treatment with esomeprazole was generally well tolerated. Conclusions Daily esomeprazole 20 mg is efficacious and well tolerated in reducing the recurrence of peptic ulcer in East-Asian patients with a history of ulcers who are taking low-dose ASA for cardiovascular protection. ClinicalTrial.gov identifier NCT01069939. ER -